FDA Adverse Event
Injury
Summary report: N
LINOX SMART PROMRI S 65
MDR report key: 2872569
·
Received December 7, 2012
Report
- Report Number
- 1028232-2012-03195
- Event Type
- Injury
- Date Received
- December 7, 2012
- Date of Event
- October 28, 2012
- Report Date
- November 28, 2012
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVY
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OUS MDR - THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE PRODUCTION PROCESS OF THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS SHOWED NO ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MFG STEPS HAD BEEN CARRIED OUT CORRECTLY. IN SUMMARY, THERE IS NO INDICATION OF A MFG ERROR.
Description of Event or Problem · 1
OUS MDR - AFTER AN UNK IMPLANTATION TIME, IT WAS REPORTED THAT THE DIAPHRAGM HAD BEEN STIMULATED, DUE TO TWIDDLER SYNDROME. NO DETERIORATION OF THE PT'S STATE OF HEALTH WAS REPORTED. THE LEAD WAS REVISED ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SMART PROMRI S 65 | ICD LEAD | NVY | BIOTRONIK SE & CO. KG | 377166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |